Policy
An unnamed FDA official also told reporters that it would be good for Moderna to “show some humility” and admit that it didn’t follow the regulator’s recommendations in testing its mRNA flu vaccine.
FEATURED STORIES
Bristol Myers Squibb, GSK and Merck are contributing drug ingredients as part of their deals with the White House but are keeping many of the terms of their agreements private.
Some 200 rare disease therapies are at risk of losing eligibility for a pediatric priority review voucher, a recent analysis by the Rare Disease Company Coalition shows. That could mean $4 billion in missed revenue for already cash-strapped biotechs.
The FDA’s rare pediatric disease priority review voucher program missed reauthorization at the last minute in 2024; advocates have been fighting to get it back ever since.
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The WHO will decide whether to declare a public health emergency following the recent outbreaks of monkeypox, and poliovirus has been detected in London water samples.
In addition to patent cases, partnerships and pledging money to global tropical disease efforts, Novartis scored a win on a combo-treatment for solid tumors.
According to a recent report, the New York City Metro area is home to 7% of the U.S. population but contains 10% of all U.S. biochemists and biophysicists and 12% of U.S. chemists.
Enanta filed a patent infringement lawsuit against Pfizer for the latter’s alleged use of its proprietary antiviral component in producing the COVID-19 antiviral Paxlovid.
Krystal Biotech announced that it submitted a Biologics License Application to the FDA for its candidate B-VEC, intended for the treatment of dystrophic epidermolysis bullosa.
U.S. President Joe Biden nominated Arati Prabhakar, Ph.D., to be his science advisor. If confirmed by the Senate, Prabhakar will become the first woman, first person of color and the first immigrant to hold the position.
The bill would curb the pricing of insulin by capping monthly co-pays for diabetics who use both commercial insurance plans, as well as the government-backed Medicare.
On Wednesday, the FDA approved Merck’s pneumococcal 15-valent conjugate vaccine for children 6 weeks through 17 years of age.
Novartis’ win in the patent dispute over its drug, Gilenya, was short-lived after a U.S. appeals court reversed its 2020 ruling vs. HEC Pharm’s attempt to create a generic version.
Acer Therapeutics and Relief Therapeutics announced the FDA has denied their NDA for ACER-001 (sodium phenylbutyrate) for the treatment of urea cycle disorders.